An interventional study of W8Loss2Go in Obesity, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
The investigators will test a recent mobile technology based (mHealth) behavioral weight loss intervention (W8Loss2Go), which is designed for children and adolescents, and uses an addiction model to promote withdrawal from problem foods, snacking, and excessive amounts at meals. The investigators will test whether this intervention will reduce body mass index (BMI), help subjects identify and withdraw from "problem foods", eliminate snacking, and reduce the amounts of foods consumed at home meals.
Background and Rationale: About one in five 12-18 year-olds in the U.S. are obese. It has been theorized that overeating in some individuals may have addictive qualities, and that specific foods may have addictive potential for these people. But few weight management interventions have tested therapeutic techniques founded in addiction medicine principles to date. Since mHealth interventions have been successful in the treatment of other addictions, the investigators hypothesize that mHealth technologies which are rooted in behavioral theory could be effective to promote weight loss in some individuals.
Dr. Robert Pretlow, together with E-Health International, created a weight loss intervention via an iPhone application (W8Loss2Go), based on the addiction treatment approach of staged, incremental withdrawal from problem foods, snacking/grazing, and excessive amounts of foods at meals. The W8Loss2Go application helps participants address their dependence on specific problem foods prior to addressing the amount of food consumed. A secondary focus of the application is to increase the amount of health provider-patient interaction outside of clinic based face-to-face-sessions in a cost-effective manner. Initial pilot studies in obese adolescents in a community setting showed success in improving these problem behaviors and improving BMI.
Intervention: The investigators will test a recent mobile technology based (mHealth) behavioral weight loss intervention, W8Loss2Go, which is designed for children and adolescents, and uses an addiction model to promote a staged withdrawal from problem foods, snacking, and excessive amounts at meals.
Hypothesis: The investigators hypothesize that participants who display addictive behaviors will respond well the mHealth intervention and will be able to withdraw from problem foods and eliminate snacking and excessive amounts eaten at meals, and will therefore show significant decrease in BMI z score from first to last visit.
Specific Aim 1: Determine if participants utilizing the app can stop eating certain self-identified problem foods.
Specific Aim 2: Determine if participants utilizing the app can reduce the amounts (portion-size and frequency) of foods that they consume in large quantities.
Study Design: New EMPOWER patients complete the Yale Food Addiction Study for Children (YFAS-c), a validated 25 item instrument designed to identify addictive behaviors related to food. Patients with more than two positive criteria on the YFAS-C will be recruited for participation in the W8Loss2Go study. Enrolled subjects and their parents will complete the Eating Behaviors Questionnaire (EBQ-Merlo 2009), and then receive the app, an iPhone 5S (if needed), a wireless body weight scale, and a wireless food scale. Over the next 6 months, subjects will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. During the six months study period, subjects will return to the EMPOWER clinic for a three month weight check and face-to face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology Study Population: Twenty obese 12-18 year old adolescents will be recruited from new patients referred to the CHLA EMPOWER Clinic.
Control Population: The investigators will utilize historical controls using newly referred patients to the EMPOWER clinic who score negative on the YFAS-c.
Methods of Data Analysis: All outcome variables will be compared before and after the intervention using paired t-tests. Further analysis will compare the results of the W8Loss2Go program to the contemporary anthropomorphic changes in patients undergoing standard care in our EMPOWER program, using two sample t-tests.
Significance: This study will evaluate the feasibility of implementing a mHealth intervention in a large clinic setting and further explore the role of food addiction specific weight loss therapies as an effective and sustainable weight management strategy for children and adolescents.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 18 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Subjects will complete all stages of W8Loss2Go mHealth intervention.
Device: W8Loss2Go
The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
Body Mass Index (BMI) z -Score
The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in BMI or a better outcome and a positive change value reflects an increase in BMI or a worsening in the outcome.
Time frame: Baseline and 6 months
Number of Participants With Success in Withdrawing From Problem Foods
The number of participants who were able to withdraw from 5 or more problem foods was evaluated.
Time frame: 6 months
Number of Participants Able to Eliminated Day Time Snacking
Success in these areas will be determined by data collected from within the application's database.
Time frame: 3 months
Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale.
Success in these areas will be determined by data collected from within the application's database. Participants will weight meals daily and the app will assist the participant in decrease the quantity of food consumed each day until they achieve age appropriate portion size.
Time frame: 1 month
18 adolescents self-selected into the app intervention. During the intervention period the app participants did not attend the EMPOWER intervention. The app program did not require parental involvement.
| Milestone | W8Loss2Go App |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in BMI or a better outcome and a positive change value reflects an increase in BMI or a worsening in the outcome.
| z-score | W8Loss2Go App |
|---|---|
| Body Mass Index (BMI) z -Score | -0.1 ± 0.04 |
The number of participants who were able to withdraw from 5 or more problem foods was evaluated.
| Participants | W8Loss2Go App |
|---|---|
| Number of Participants With Success in Withdrawing From Problem Foods | 18 |
Success in these areas will be determined by data collected from within the application's database.
| Participants | W8Loss2Go App |
|---|---|
| Number of Participants Able to Eliminated Day Time Snacking | 18 |
Success in these areas will be determined by data collected from within the application's database. Participants will weight meals daily and the app will assist the participant in decrease the quantity of food consumed each day until they achieve age appropriate portion size.
| Participants | W8Loss2Go App |
|---|---|
| Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale. | 18 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| W8Loss2Go App | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
Of the 50 eligible adolescents approached, 18 elected to participate in the app intervention
| Age, Categorical(Participants) | W8Loss2Go App |
|---|---|
| <=18 years | 18 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | W8Loss2Go App |
|---|---|
| Median | 14.44 ± 1.65 |
| Sex: Female, Male(Participants) | W8Loss2Go App |
|---|---|
| Female | 13 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | W8Loss2Go App |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | W8Loss2Go App |
|---|---|
| United States | 18 |
| zBMI(z-score) | W8Loss2Go App |
|---|---|
| Mean | 2.21 ± 0.45 |
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Plan to share: No — The individual participant data will be de-identified and coded. The sponsor of the study will have access to this data through the application download. The data will not be available to the public.
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